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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 10 FDA device recalls.

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DateProductReasonClassFirm
Nov 20, 2023 AirFit N20 Nasal Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets that have potential ... Class I ResMed Ltd.
Nov 20, 2023 AirFit F30i Full Face Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets that have potential ... Class I ResMed Ltd.
Nov 20, 2023 AirFit F20 Full Face Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets that have potential ... Class I ResMed Ltd.
Nov 20, 2023 AirFit N10 Nasal Masks and User Guide Masks non-invasive interface for channeling airflow to patients have magnets that have potential ... Class I ResMed Ltd.
Nov 20, 2023 AirFit F30 Full Face Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets that have potential ... Class I ResMed Ltd.
Nov 20, 2023 AirTouch N20 Nasal Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets that have potential ... Class I ResMed Ltd.
Nov 20, 2023 AirTouch F20 Full Face Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets that have potential ... Class I ResMed Ltd.
Sep 13, 2023 Astral 100 and Astral 150 ventilators If ventilator is on internal battery, not intended to serve as a primary power source, low/critic... Class I ResMed Ltd.
Dec 12, 2019 ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 Combination of software and a component failure may cause audible alarms not to operate properly,... Class I ResMed Ltd.
May 5, 2015 Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. The Astral device allows clinicians to disable all alarms including those that detect circuit dis... Class II ResMed Ltd.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.